we are funded by these television companies and more, including charter communications. >> charter is proud to be recognized as one of the best internet providers, and we are just getting started, building 100,000 miles of new infrastructure to reach those who need it most. >> charter communications suppor c-span as a public service, alo with these other television providers, giving you a front row seat to democracy. and now president trump's nominefoodnd drug and commissionerarty makary at his confirmation hearing, he took questions and drug shs, food safety come and was asked about his opinion on prescription requirements for mifepristone, the prescription drugs end premises. this hearing is about one hour and 45 minutes. [indistinct conversations]

chair cassidy: the senate committee on health, education, labor and pensions committee. four please come to order. thank you, dr. makary, for appearing before us. trengthens adversaries i've spoken to many officials from the region there, and they explained to me their shock when they would prepare for meeting with the secretary blinken. they prepared about how to work together to combat china. but when they had the meeting, they were hit about the climate, about the lgbtq, the agency should look at ways to address bottlenecks and review processes, including artificial intelligence and other technologies to improve efficiencies and accelerate drug

discovery while ensuring these products are safe for americans. another topic of interest is food safety. americans deserve to know that the food they bought for their families is safe to eat. one place to start should be the fda review process to ensure the safety of ingredients that go into foods. i know dr. makary is passionate about this issue. i look forward to working with them, if he is confirmed. the american people's trust in the product they regulate must be restored. public confidence is especially important as we respond to measles outbreaks and investigate recommendations for vaccines and food -- flu strains ahead of the upcoming flu season. dr. makary, with his experience as a surgeon and effective health policy communicator can help out public agencies rebuild trust with the american people. thank you for appearing before the committee.

and discussing your vision on how to make america healthy again. senator sanders is not here, so dr. makary, we will go to you for your opening statement. dr. makary: great, thank you, senator, dr. cassidy, ranking member sanders, and members of the committee. i'm humbled to be before you here. i would like to thank president trump for his confidence in nominating me to lead the food and drug administration. i'm joined today by my wife, my sister maria, my brother mark, alexander, jacoby, and my very sacrificial mother, and my career role model, my father. my father dedicated his life to the care of children with leukemia, lymphoma, hemophilia, sickle cell disease, and then turned his attention to adult

hematology could his father, my grandfather, was a pharmacist and a poor egyptian a community and believed in treating everybody equally, especially the most vulnerable among them, a philosophy i've tried to emulate in my own career and research. even from an african continent, my grandfather looked to the u.s. fda for just guidance, because the fda has a gold standard to uphold public safety and help us as clinicians take care of patients when they come to us for help. as a kid, i vividly remember being in a grocery store in our small town with my dad when somebody would stop him, break out in tears, and give him a long hug after what i would learn to be a decade-long battle with lymphoma. it happened a few times, and each time, it inspired me even more. for 22 years now, i've had the

privilege to walk into the johns hopkins hospital, to live out that mission, and each morning as i enter the front door, i pause and look at the nine foot statue of jesus that stands in the center of the hospital lobby, and i've read the sacred text engraved at the base, "come to me, all ye who are heavy laden, and i will give you rest." i'm grateful to johns hopkins for allowing me to have a creative career, a dual career as both a surgical oncologist and a health care public policy researcher. in addition to using fda-approved devices and medications, my research, which has now spanned over 300 scientific peer-reviewed articles in the medical literature, has focused on what is actually making a difference in helping people, and how health care has become too fragmented, too cold, and to corporate.

my research and subsequent book on price gouging and predatory billing and health care turned into advocacy to demand more transparency in health care. president trump heard the plea and invited me to the white house in his first administration to enact the nation was the first executive order to bring down hospital and drug prices through greater transparency. the reform was entirely bipartisan, just as president trump and secretary kennedy's call to make america healthy again, by finally addressing the root causes of our child chronic disease epidemics, which is resonated with moms regardless of politics across the country. it should be a goal we can all agree on. as a scientist who has spent a career evaluating medical interventions, i believe in the scientific process. in addition, i also believe that we can use common sense.

dr. cassidy, as i have been in the operating room, as you would relate, it's hard to perform a long sophisticated operation for liver cancer and not ask, why are rates of liver cancer triple in the united states? we don't have a generational opportunity in american health care. president trump and secretary kennedy's focus on healthy foods has galvanized the grassroots movement in america. childhood obesity is not a willpower problem. a rise of early onset alzheimer's is not a genetic cost. we should be and we will be addressing food as it impacts our health. thanks to the courage of president trump and secretary kennedy, we now have a generational opportunity to usher in radical transparency, facilitate more cures, meaningful treatments, and diagnostics at the fda to help people take care of their own health.

my father told me to write down my observations and my experiences in health care and the research i delved into. much of the research i did focused on the fundamental question, is what we are doing working? i wrote books to educate the public on medical science and to empower them to live healthier lives. if confirmed, i hope to ensure the fda holds to the gold standard of trusted science, transparency, and common sense, to rebuild public's trust and make america healthy again. thank you, mr. chairman. chair cassidy: thank you, dr. makary. i will start with questions. in 2021, a few months after president biden took office, the fbi announced it would no longer enforce the in person dispensary requirement for mifepristone, the drug which obviously is an abortive drug.

this is concerning to me. there is a case out of louisiana in which there was no recognition of the drug for the patient but someone who was going to allegedly coerce the patient into taking the medication, which would have been a bad position. so, if confirmed, would you reinstate the in person dispensary requirement as well as reporting requirements for adverse events and other complications associated with drugs? dr. makary: thank you, senator. to take mifepristone is deeply disturbing and i might even suggest criminal. i have no preconceived plans on mifepristone policy, except to take a solid hard look at the data and to meet with the professional career scientists who have reviewed the data at the f.d.a. and to build an expert coalition to review the ongoing data, which is required

to be collected as a part of the program, the risk evaluation and mitigation strategy. it is pursuant to rems. >> it meetings to select anticipated virus for next year's flu vaccines. now, i'm told by people who are familiar that the f.d.a. will make the recommendation and that they will come up with the right decision. but they also say what is lost is the transparency. because the open meeting allows the post mart 'em, if you will -- a post mortem, what went right and wrong and how to make it better. i think one of the laudable things about secretary kennedy's positions is he wants more transparency in terms of how the federal government makes medical

decisions as part of restoring that faith. so frankly, this seems to kind of go backwards on that. so how will you ensure that advisory committees remain objective, transparent, and still benefiting from the necessary expertise of external experts? >> senator, thank you for the question. i was not involved in that decision certainly confirmed once in office, you have my commitment toe take a look at it. as you know, that committee takes a look at guidance and recommendations from international groups, such as the g.i.p. international consortium. my understanding is at least for the last seven or eight years that i've been following that group, we have simply rubber stamped whatever the international -- >> for a second, my understanding, these strains

typically begin like in australia or china. it isn't so much of a rubber stamp, but as much as recognizing what are you seeing, because that's what's coming to us. so just, it's more than quibbling to say that you're learning from it. your thoughts? >> yeah, so the american public deserves confidence that scientists are looking at that data from the southern hemisphere. it's all reported into a registry, all the dominant strains, and then picking the most dominant strains that are lighting up in that registry is that process of really trying to estimate which strains are going to be dominant in the united states. it's not very precise. they don't get it very well. but it's the best we can do with the data we have available at the time. the group, for example, the international g.i.p. group chose to no longer include the influence of e strains a couple of years ago. sounded like a very reasonable decision, and they also went along with the recommendation.

but i think we're aligned in that the american public want to have some confidence that independent scientists are looking at these data. >> and going back to the transparency, with the open meeting,s transparency. how can you as f.d.a. commissioner advocate for that transparency? because we want the american people to know, and obviously the meet will go kind of shut that door a little bit. >> yeah, so senator, i was not involved in that decision. >> i accept that. and again, how are you going to make it happen, i guess that's my question. >> so you have my commitment to review what the committees are doing, how they're being used, as i was critical when that committee was not convened at all during one of the covid booster guidance decisions by the f.d.a., and the f.d.a. career and leadership at the time argued that they're

advisory, and we don't have to screen them. that was repeatedly throughout the biden administration and there may be some value, if there's a step where the efficiency can be made, but i think with something that's important, something that's critical, something we want expert opinion, it not only provides some of that wisdom, but it also increases the perception of confidence from the general public. last week i asked about the cancellation of that vaccine advisory committee meeting. there's information this is a meeting that takes place annually for at least 30 years to make recommendations on which influenza strains should be included in the flu vaccines for the upcoming flu season. there's no explanation given, no new date chosen.

that is, i believe, unprecedented and dangerous, and you just referred to it, dr. makary, in 2022 you raised concerns when the f.d.a. was considering not olding a vaccine committee meeting to authorize covid-19 boosters for kids 12 to 15. at the time you said it was "unconscionable and undermined the integrity of the f.d.a. standard process to not hold that committee meeting." so if you are confirmed, will you commit to immediately reschedule that f.d.a. vaccine advisory committee meeting to get the expert views? we need to know those so we can have the current vaccine for the upcoming flu season. >> thank you, senator, for the question, and i appreciated our time together in meeting ahead of the hearing. i was not involved in that decision. >> i'm asking if you will immediately reconvene it. >> i will immediately

re-evaluate which sessions, the leadership of that center, which decisions, which topics could benefit -- >> a reevaluation, if it's done every year so we know what flu vaccine to have. what are you re-evaluating? >> first of all, for the last seven or eight years that i've been following, they simply adopt verbatim the recommendation of the international g.i.p. group, but i was not involved in that decision. i will say that, in my opinion, it was a huge difference between requiring every 12-year-old girl in america to take an eighth covid booster shot versus rubber stamping a recommendation from the international g.i.p. group, which has done seven out of the last seven years. i'm not saying that decision is something i was aware of or involved in, but it's certainly something i will look at, if confirmed. >> ok, i'm very unclear, because the f.d.a. is the gold standard for all of us. and this committee hearing is

what has always been what we look to, the f.d.a. looked to, the american people look to, to determine what the flu vaccine is. what are you going to look at to make a determination and figure something else out decades into this? what are you re-looking at? >> senator, i was not involved in that decision. >> i understand that -- >> i committee that -- >> i was thinking you would say we'll look at it immediately so our doctors know what flu vaccine to have next fall. >> as i understand it, the committee members and the scientists at the f.d.a., the career professional scientists at the f.d.a., look at the recommendation of the international g.i.p. group -- you know a you know you just told me you were going to re-evaluate it, and i want to know what you are re-evaluating at. what are you looking at to make a decision whether to reconvene it? >> in conjunction with the center director of the biologic center, i would re-evaluate

which topics deserve a convening of the advisory committee members and which may not require a convening. >> what would you base that decision on? >> you can ask the biden administration that chose not to convene the committee meeting for the covid booster. >> i get that, i understand. but i'm asking you. how will we know what flu to take next year if this committee doesn't reconvene and make the recommendation? >> senator, i was not involved in that decision not to convene that group. >> let me just ask you really quick, also following up with another question on mifepristone, because f.d.a. does play a really critical role in making sure we have safe and effective medications. contraception and medical abortion have been approved by the f.d.a. for many, many decades, based on mountains of

high-quality evidence and expert scientific judgments. so if you are confirmed, will you commit to upholding the science and evidence-based drug approach for all f.d.a.-approved products, including contraception and medication abortion? >> thank you for the question, senator murray. you have my commitment to follow the independent scientific review process at the f.d.a., which is a tried and true process, which has been around. that is my commitment to you, senator. >> i want to be clear, there's been over 100 high-quality studies over more than two decades backing up the science and safety of mifepristone. thank you. >> senator paul. >> congratulations, dr. makary, on your nomination. i think one of the most important things we need in government are people who are open-minded. i think close-mindedness, the idea that this is settled and no one will ever -- if you see data at the f.d.a. and have to make a decision, are you willing to

lead where the data and the facts take you as opposed to your preconceptions? >> absolutely, senator paul. i think it is part of being a scientist. we need more humility in the medical establishment. you have to be willing to evolve your position as new data comes in. >> the people who aren't involved in science think it's settled, it's just all settled, and we should just all be quiet and submit to whatever settled science is. you mentioned that yesterday you removed a gallbladder through a laproscope. i was in medical school about the time where everybody made four or five-inch incision to take the gallbladder out. and the older surgeons, the consensus, they ran the surgery departments, they were like, it's malpractice to use these tiny incisions and blow the air into the abdomen and do all this. but it took an overcoming of the

consensus. do you remember some of that? might have been a little after your time, but do you remember the larger incision and small incision and the resistance of the consensus? >> oh, yeah, senator. i can tell you some of the surgeons who trained me said things like, surgeons use big incisions and the bigger the incision, the better, and without having a big, open incision, you can't really see what you're doing. i would point out that a laproscope gives you 10 times the magnification. there's a lot of medical dogma that has contaminated our field. i think it's tied to a lack of humility. ultimate what will makes a great doctor, in my opinion, as i teach my residents, is not how much you know, it's your humility and your willingness to learn as you go from patients. i think some people here are also not duly impressed enough by what it takes to do the kind of surgery that you do. i'm an ophthalmologist, and we do really tiny incisions, but our surgery lasts between five

and 20 minutes to take the cataract. you've bone whipples, a surgery on the liver. how long does that take? i've done a lot of eyelid trance pant procedures, and then pioneered a new type of procedure, which is a lapro cop i can transplant with hopes that it can someday be used to secure diabetes. it was about eight hours for that operation when we started. we've gotten it down to about four or five hours. we've done some whipples in three hours. >> with regard to the vaccine committees, and they talk about whether they meet or don't meet and things. there have been some questions, and one of the questions that i've been bringing forward is whether or not there could be a conflict of interest. one of the things i've asked, and you would think it would be universally accepted by everyone without question is, you should have to reveal if you get royalties from drug companies. so if you're make a decision on

a pfizer vaccine or moderna vaccine, i would think the least of the transparency should reveal if you get royalties from those companies. do you think we need to evaluate the people on the committees or see whether they get royalties or see whether or not there are conflicts of interest for the people making these decisions? >> yes, i do, senator. we need to review the ethics policy, because people see things that appear to be a cozy relationship between industry and the regulators that are supposed to be regulating the products. now, i want american companies to thrive. i want life sciences companies to thrive. but we need to call balls and strikes and keep that independent scientific review process free of any conflicts. so i do think it deserves a look. >> i think it would be an area that a lot of people think there's a consensus to take all the covid vaccines or not, most of europe doesn't recommend it for under age 12.

almost all the countries don't recommend it. some under 18. and it's because they looked at the risk-benefit for children of the vaccine, and some of the possible complications of it. it's different, frankly, for older people. these are things that we should at least discuss and evaluate. some of the most pro-vaccine people, when the policy came out to give boosters to your 6-month-old, said they wouldn't even give it to their 24-year-old, a booster. you remember one of the famous committee members, two committee members left the vaccine committee because the c.d.c. under biden politicized the process and overrode the vaccine committee. so to insinuate that somehow there's some brand-new thing going on, these are long-standing controversies, and i think that the main thing i would go back to in the beginning, we need open-mindedness, and i appreciate your willingness to look at the facts, the data, and not be overwhelmed by preconceptions. >> senator baldwin.

>> i want to go over a couple of topics that have already been raised, and if we have time, explore one that has not yet. i want to understand your position on mifepristone. we had an opportunity to speak in my office. i thought that you were pretty clear with me during that meeting that you were aware of the overwhelming scientific becomes conclusion about the safety of this medication and you did not think politics should be involved in decisions moving forward. and i understood from our conversation that you intended to stand behind the f.d.a.'s long-standing determination. but after our meeting, i don't know if it was you or your minders, but they followed up with my staff and said they felt

that you misunderstood my question. and wanted to clarify your answer. which, by my read, implied that you are open to totally re-examining the scientific determination, even with decades of evidence. so i want to clearly understand your position. ads f.d.a. commissioner, will you maintain current access to mifepristone, yes or no? >> senator, i'll be very clear about my position. my position is that of a scientist. as you know, part of the rems, the risk evaluation mitigation strategy that was put in initially by president clinton and that administration, and then modified under obama and then again under president biden, requires ongoing data collection. so i can't prejudge that data without looking at it. >> so you said something about convening an ongoing panel.

>> i did not mention -- >> a previous question just asked. >> i did not mention a panel. i said i would convene the scientists that are professional career scientists at the f.d.a. who have reviewed the totality of data on this and are also looking at ongoing data that is being collected. there could be, for example, senator, a drug-drug interaction that may show up in the ongoing data. >> so i want to ask, if that's your approach to something that has been approved for decades, are you going to do the same with tylenol? there are a lot of side effects for daily use, including liver damage. will you be doing that for tylenol? >> as you may know, senator, tylenol does not have a regulation requiring a rems. >> i'm not asking whether it does or not. i'm asking, are you going to do ongoing surveillance of the

possible side effects for that drug that was approved many years ago? how asthma inhalers that have been associated with osteoporosis, opportunistic lung infections. are you going to be doing that for those medications? >> senator, i will be following the law and the regulation requires an ongoing -- >> you have a totally different approach to this. again, a little bit more about what we're talking about with the influenza vaccine and vaccines in general. as has been said in this hearing, the advisory committee annual meeting was cancelled for selection of what strain of influenza our vaccines or this next season would confront. there have been additional reports that secretary kennedy wants to make significant changes to another advisory committee that makes

recommendation and provides advice to vaccines, for vaccines. and i worry that this is merely a ploy to install vaccine skeptics on these critical panels. our advisory committees must maintain scientific integrity and should not be changed for political purposes or to further an agenda. so dr. makary, do you intend to remove experts from the vaccine and related biological product advisory committee? >> senator, first of all, i'm not familiar with what you're referring to regarding secretary kennedy. secretary kennedy wants to make america healthy again. with regard to the vaccine committee, deciding on which flu strain to identify, i was not involved in that decision. but again -- >> are you planning, if confirmed, to remove any experts

from the vaccine and related biological product advisory committee? >> i have no preconceived plans to rearrange that committee or any committee. i will say on influenza -- >> do you commit to maintaining scientific integrity on advisory committees and receiving regular outside expertise if confirmed? >> of course. >> ok. >> senator collins. >> thank you, mr. chairman. first of all, i appreciate your i appreciate your willingness to serve and what has been as a result of our conversation. you have had a lot of questions about the vaccine from the advisory committee. let me ask you a simple question. if you are confirmed, will you

reinstate meeting with the committee? dr. makary: the committee will be meeting if i am confirmed and i'm commissioner, yes. sen. collins: we learned hundreds of probationary employees at fda were dismissed. this really concerns me because you need a flow of young new researchers and scientists. we are seeing retirements and resignations. ironically, more than a half of the fda employees are funded under various agreements. there is revenue coming into the fda to pay for these employees. if confirmed, will you, not an outside force, have full

authority over fda staffing decisions? dr. makary: senator, if confirmed as commissioner, you have my commitment that i will do an assessment of the staffing and personnel at the agency. i have not been involved in any of the decisions. if confirmed, you have my commitment that i will do an assessment. sen. collins: i just want to make sure that you are the one doing that assessment. i'm not saying the staffing level is perfect and i think it is helpful for a new commissioner to do an assessment but i want that person to do it. it sounds like you are committing to that, is that correct? dr. makary: i will do an assessment, yes, senator. sen. collins: one of the best ways to lower the cost of prescription drugs is by

promoting more market competition. and one way we can do this is by making it easier for generic and bio similar drugs to come to the market. as part of a broader bill that senator shaheen and i have introduced to help lower the costs of insulin, we have included a provision to create a new competitive bio similar pathway and therapy designation under which eligible products for which there is inadequate bio similar composition now could achieve expedited review. i've worked with the fda in the last congress to develop this provision. i look forward to continuing to push this concept so that it becomes law. do you support the concept of a

new expedited pathway for bio similars to compete, for example, with branded insulin? dr. makary: first of all, you have taken a strong interest in the fda and i very much appreciate it. i have really enjoyed our time together. i have learned from you and thank you for your leadership on the diabetes caucus. i am a big believer that we need to figure out a way to get bio similars approved quicker without cutting corners on a scientific review. it is one of several strategies that the fda can do to try to alleviate the problems of high drug prices, inadequate competition, or underperformance of competition and the drug shortage in the united states. also, other strategies could

include the way we look at generic drugs. moving medications to over-the-counter. does naloxone really need to be a prescription only medication? does an epipen need to be prescription only? they can be over-the-counter and we can feel confident about public safety with those products on the shelf at the pharmacy. it would force the companies to put a price on the shelf and i do believe in price transparency. it will have an effect on the entire marketplace so thank you. sen. collins: let me just end by saying that i am delighted with your interest in therapy for individuals with type one. that are clinical trials underway and i think that is such an exciting development. thank you. dr. makary: thank you. chair cassidy: now, senator hassan. sen. hassan: thank you.

good morning and congratulations to you and your family on your nomination. president trump has promised to help lower cost but prescription drugs are skyrocketing for granite staters and all americans. in 2025, drugmakers have increased the list prices of over 500 common medications. dr. makary, you and i discussed the importance of increasing generic drug competition. if confirmed, will you work with me to speed the approval of generic drugs and fda to lower drug costs? dr. makary: first of all, i enjoyed our meeting together. the answer to your question is an emphatic yes. i would add to that that i would love to work with congress to address a way that patent law has enabled patent thickening which makes it difficult for bio similars and even drugs to come to market because they have the navigate so many lawsuits and the letter of the patent

law. sen. hassan: this is something senator paul and i have been working on and we have a bill called increasing transparency drug act which would allow the fda to communicate more transparently with generic drug manufacturers in order to make more low-cost prescription drugs available for patients. the bill would save taxpayers over $1 billion and has bipartisan agreement. i will urge all of my colleagues to look at it. i have enjoyed working with senator paul and his team on it. dr. makary, you and i also discussed when we met a medication that has been used in abortion and miscarriage care. you said you were not familiar with the drug and i followed up with decades of safety data and you said you would review it. have you reviewed the data and do you agree it is safe and effective? dr. makary: thank you for sending me that homework to read.

i did read those articles, including -- what now is referring to when i set i was not familiar with it, and i don't believe i said i was not familiar with it, i said i have not reviewed the totality of the data. i'm very familiar with mifepristone. i read those studies including surveys of patients inquiring about telemedicine. a 2018 national academy of medicine review. i'm a member of the national academy of medicine but not involved in that particular review, but i did review that document. sen. hassan: i shared with you that study from the national academy, where scientists looked at over 100 studies of medication abortion and found the literature is clear that mifepristone is safe and effective. also, we've had the discussion about the rems process. in 2021, the fda looked again, based on a citizen petition,

look at the safety of mifepristone. this is the report about their review and about their modifications of the language in the process. their review that it is safe and effective. i think what you are hearing from a lot of us, so the public can understand, there's lots and lots of data here that supports the safety and efficacy of mifepristone and supports the efficacy under current law and safety. so, i think the concern you are hearing is not about whether you will follow an ongoing process with any medication and look at the most current data. that is what the scientific process is about. the concern is whether you are going to unilaterally overrule the data that currently exists for political purposes and for political reasons. that is what we are looking for your reassurance on. you have told us you are an independent scientist, i believe that. you have a distinguished career

as a physician but we need to know that when you say you are an independent scientist, that is really what you mean and when the politics get heated around abortion, that you won't abandon that independence. dr. makary: senator, you have my commitment that once i am in office, i will do a review of the data. i have no preconceived plans to make changes to mifepristone policy and i do plan to follow the law and the regulation to look at ongoing data. they could be that there could be a interaction we can identify. sen. hassan: i understand that but what i am looking for is an understanding that the current state of science and the process that you have been a participant in through your entire korean others up here have also participated -- your entire career and others appear have participatedin, that you will follow the science and not unilaterally overrule scientists

because you are under political pressure to do that. dr. makary: if you look at my track record, i have never been afraid to speak my honest scientific opinion. and i have no preconceived plans to make changes on that medication. sen. hassan: i wish you were hedging a little less today. thank you. chair cassidy: senator murkowski. sen. murkowski: thank you. i understand the senator from alabama has an engagement so i will defer my time. florida. [laughter] chair cassidy: that will lose you votes in florida, but go ahead. >> thank you, i am so grateful. i'm so lucky to be able to question before the senior senators. i'm grateful to all of you. so honored. i'm so excited to see you here today. i was incredibly happy with the nomination.

i know you will do a great job. i have two issues i want to cover. they are relevant specifically to the two main roles in my life over the last six years. one as a mother and one as attorney general of florida. first, i want to talk to you about what is going on with the fda and its burying its head in the sand about illegal chemically written extraordinarily high amounts of nicotine, chinese vapes that are flooding the united states market. two thirds of the export market from china for these vapes, to third our chinese vapes coming out of china. it is unbelievable. they are in flavors like strawberry blow pop, watermelon, sour berry. attracting children, addicting children. we have so many, thousands and thousands of pending applications, most of these

things are illegal in the united states right now. yet somehow, china has decided to flood our market with the legal vap -- illegal vapes and they are benefiting. in china, they banned flavored vapes. so, all of the manufacturers there of the chemically ridden vapes are flooding our market and addicting our children, just like how we are seeing harmful substances coming from china. fentanyl, etc. so, whoever comes in as the head of fda, this is one of the problems you have to address immediately. i know there are a lot of things you will get questions about, but these things are all over the united states. convenience stores. they are readily available to children. you would be able to find them. not only are the amounts of nicotine going up and up, we

don't know what is in these. there has been little to nothing done to deal with our pending applications at the fda or to enforce those that we know are illegal right now. how would you address this and what do you plan to do on day one? dr. makary: i appreciate your passion on this important issue. i've appreciated your work as a attorney general in florida on this issue. maybe it is because you believe in doing the right thing and you are a baseball mom. i think there are four new va ping stores that have popped up in my neighborhood the last few years. i have not walked into one of them, although perhaps i should to check it out. you're absolutely right that we are being flooded with chinese products. we have no idea what's in these products. and public health is not going to be able to study them because

it takes so long for public health research to catch up. but, it is very concerning and it is not right that the products are banned in china but they are sending them to the united states. there are a few things the fda can do. the office of inspections and investigations has a lot of people with guns and they do enforcement and raids. we need in collaboration with doj and other areas of law enforcement to try to address this problem of illegal products on our market. sen. moody: there was an announcement during the last administration -- once people finally convinced them this is out of control that people are getting addicted, there was this big announcement of task force using all the tools available. that is great. florida has to step up and do it ourselves because the federal government would do nothing, but the first key is what to do with our pending applications. how do you clean up fda's health

first. you need to know what the law is. let's start there, please focus on that, and then we will also work with the enforcement measure. i would like to get a commitment from you. citrus growers, orange growers, that is a big deal to us. there's an arbitrary regulation about sugar content. it needs to be examined with all the things facing the industry. that arbitrary regulation -- why have your commitment to them to look at that regulation, things that are set sometimes that we need to revisit on how it is affecting industries across the united states, i have your commitment to look at that? dr. makary: i had my coldpressed freshly squeezed orange juice this morning and you have my equipment. sen. moody: our orange growers will be happy to hear that. thank you. chair cassidy: that was a great board that told you to drink the orange juice.

senator kim. sen. kim: thank you, chairman. thank you for coming out. i was looking through your open statement. at the end, you talk about the fda being a gold standard, you said at gold standard of transparency. i wanted to ask you in terms of transparency, do you think it is important that we can ensure there is public comments on actions of agencies and departments overseeing important aspects of our lives? dr. makary: senator, first of all, it was good to meet with you. i do believe in civil discourse and have been an advocate for civil discourse coming out of an era of medical establishment censorship. there are laws and regulations around public comment periods and in some situations, a public comment period is required by regulation.

sen. kim: i would suggest this is really important. we have had a long conversation about how to restore trust. i think a big part of that is about involving the public. i think you saw some of that in terms of the questions regarding the need for that type of radical transparency as secretary kennedy talks about. recently, there was an effort, the richardson waiver. i asked that you look into this. i think it is important that we maintain public comments, something that hhs has not abided by an something that has been long-standing practice. another aspect is about transparency and accountability. i just wanted to ask you if we have a sense of nothing to hide and want to root out waste, fraud and corruption, do you support the rules of -- roles of inspector general? dr. makary: i believe in the law and i believe in the process of

having inspector general's. sen. kim: if you are confirmed, i urge you to do everything you can to ensure that hhs has an inspector general, has the ability for us to be able to oversee the accountability and root out some of the problems that i hope both of us can agree upon. i just want to ask for your commitment on that front that you will push to try to have an inspector general at hhs. when it comes to ethics, i heard you talk about having an ethics review in terms of positions people might be having, especially involving approval of drugs. i wanted to ask you more, it looks like i came across something saying that you were willing to divest from your own investments that were being perceived potentially is a conflict of interest if you are confirmed in this job, correct? dr. makary: as you are aware, the office of government ethics has a comprehensive review of basically everything i own,

every stock, every share. i would describe it as a colonoscopy with a small follow-through. it took about four weeks. they gave me the option of resigning from some things or maintaining a role and i chose, voluntarily, to divest and resign from everything. sen. kim: i applaud that and i think that should be the standard, especially for such an important job. i wanted to ask you a little further here. would you agree to recuse yourself from matters involving your former clients and employers if that comes before you at the fda? dr. makary: what i can promise you and commit to is to abide by all the guidance of the office of government ethics. sen. kim: i understand that but you talked about how you voluntarily took steps to divest, that was not something you are required to do, although i think you should have been. i will ask you again, will you

consider recusing yourself -- again, if you are making decisions about a previous client of yours, you can see how the general public would react to that in terms of the concern about whether or not you are doing this for the best interest of the people were the best interest of people you know. dr. makary: senator, i have signed to agree to refusals as defined by the office of government ethics. any area where they perceived a conflict could occur so i have already agreed to refusals required by the office of government ethics. sen. kim: one last thing i wanted to raise. this is something -- i want to ask, what is your feeling about these potential medicaid cuts that are being reviewed right now in congress? dr. makary: as you know, the fda is not involved in medicaid or coverage decisions. sen. kim: i understand that. the reason i raise it is the opening remarks you said, you

said that your motto in life has been about treating everyone in the community equally, especially the most vulnerable amongst them. i just urge you to continue to -- you won't have a seat at the table on health care decisions across the administer ration. medicaid is essential for the most vulnerable amongst us and treating everyone equally. it is not just about the approval, you want to see that get into the hands of americans and make sure they can benefit from them. i do think you have an interest in preserving medicaid. thank you. chair cassidy: senator murkowski. sen. murkowski: welcome. it was a good conversation that we had. i appreciated that. the encouragement to read the provision in your book. dr. makary: thanks. sen. murkowski: i also want to thank you for the assurance you gave senator collins regarding the vaccine advisory committee and ensuring that there would be meetings going forward. i think for several of us, i

thought good substantive conversations with secretary kennedy. we had received assurances about things like the vaccination committee. making sure that kind of very important input goes forward as it is important to many of us. i wanted to talk to you this morning about an issue that we discussed in my office. that is with regards to als. the fda' accelerated approval pathways has really been important and promising for treatments of als and other rare diseases. you have advocated for using common sense alongside science and regulatory decisions. very briefly, how do we define common sense here as it applies to the regulatory decisions of fda? how do we make sure that als patients, who again, are looking

at a very limited timeframe. they cannot wait for the traditional approval process. there are some emerging measures using digital technology. is this in your realm of common sense? give me a little bit of your view on how you would like to see these accelerating approval pathways? dr. makary: i very much enjoyed our time together and talk you through a bunch of these issues. we have to customize the regulatory process to the condition that we are trying to be able to offer hope for. a condition affects 19 people in the world as a partial, chromosome 15 disorder, or a disease that affects 52 kids in the world, we cannot require two randomized controlled trials.

we have to customize the regulatory process to what we are trying to do, if our goal is to try to provide safe and effective therapies. so, i do believe firmly in that approach and i think we could use some common sense to ask some big questions we've never asked before at the fda. why does it take 10 years for a drug to get approved? why does a college student who suffers from chronic of domino pain for years, they go to italy for a summer and they are suddenly cured of their abdominal pain? why does a peanut allergy medication that has been safe with data get approved in europe before the u.s. when nearly 10% of our population has a food allergy? i do think there's a lot of areas we can ask does a drug need to be prescription when it can be over-the-counter? why are we requiring continuous glucose monitors to have a doctor's prescription? when it is good for people to

use these monitors and learn about what they are eating. we don't just want to limit continuous glucose monitoring to people with diabetes. we want to prevent diabetes. when 30% of our nations children has diabetes or prediabetes, why are we holding these tools to help people until after they are sick? same with continuous blood pressure monitoring. sen. murkowski: why do we wait? we want to make sure there is a level of safety, that is the job through the fda, but again, being able to accelerate these in ways that are meaningful, and to your point, that actually fit with the population you are speaking to. know i will be pushing you on this, as well as many other advocates. i want to quickly ask you about food safety inspection. state, local governments conduct the 60% of food processing

facility inspections. 90% of inspections, 100% of retail food inspections. what has happened is we have seen in the biden administration fda planning to cut funding for state and local food safety programs. this impacts us in the state of alaska when it comes to the seafood industry and other areas. i am looking for a commitment from you that under the trump administration, the fda will maintain funding to these contracted states and local governments. they have proven it is more cost-effective, more efficient and also is what congress has asked for. i would like to know if that will be supportive. dr. makary: i am happy to look at that with you. chair cassidy: senator blunt rochester. sen. blunt rochester: thank you

so much for taking time to meet with me. i found that most parents will do anything to keep their children safe and healthy. which is why we probably see so much on the best ways to protect our children. the fda has historically been seen as the authority on reliable information about public health issues related to medical products, food, tobacco, cosmetics, dietary supplements. however, people are getting their information in different ways now from different places. we are faced with a growing challenge of opinions replacing scientific consensus and the proliferation of misinformation and disinformation. parents need accurate, science-based information to help make informed decisions for their children. how would you use your position as fda commissioner to compete with uninformed voices and to share evidence-based, consensus

driven information that is free from political influence? dr. makary: thank you. i enjoyed our time meeting together. i believe very much in empowering peopl with good information. thate is why i have written three best-selling books to try to educate people about health. i think you can explain to people with humility what they know and what they don't know. and they will trust us more. it was 71% in 2014 and now it's down to 24. if we have a cure for pancreatic cancer but only 40 percent of the public is going to come in and take us and the rest doesn't trust us that medication is only 40 percent effective. i think we fight ideas with more ideas.

i don't believe in censorship of scientific opinions. we have a toxic discorse in the united states with immune cells. >> one of my concerns is who those voices are and if they are robust messengers as well. we're threatening access from products that we use every day. do you agree that the fda should play a leading role in mitigating drug shortages.

dr. makary: i love yes and no question. >> can you do it? dr. makary: i would refer you to my article in jama on this topic >> so again yes or no due believe that clinical trial diversity is critically important? that is an easy one dr. makary: if you are talking about a trial of sickle cell disease? i believe in common sense and i believe in clinical trial diversity both. i believe if you are going to make results extrapolated to the general population you should have results in those populations that you are making recommendations for. >> that one was an easy

one. do you think it's acceptable to remove a mandated guidance document on trial diversity. >> i'm not familiar with that. >> should you be confirmed would you rye could yu reinstate looking a the that document? >> yes. >> good answer. would you restore the website of the minority of health and equity. >> i'm not familiar with that website. >> if you new there was a website would you restore that for the american people. >> you have my commitment to take a look at it. >> if you got an opportunity to review the website and know that it would help to spread real information

science-based information, would you reinstate that website. >> i would be happy to review it. >> i have more questions that i would send as for the record, but particularly i'm concerned also about the vaccines for children program and making sure you heard our colleagues about the cancellation of the meeting. this is not just about cost for families which is huge right now, but it's also about coverage. you will back my time and i thank you so much, doctor. >> thank you senator. >> doctor it's great to see you again. i enjoyed your conversation and congratulations on your nomination and thank you for your willingness to take on this very important roll. you have been asked about this several time already. in 2000 clinton's fda approved a chemical abortion. now the fda concluded mifepristone could not

be safely used without special measures and it's the fda's language. and, in particular, fda mandated that they must be licensed to and the fda further required that these drugs be administered and dispensed in person and there be a day one in person administration of the drug and a day three administration of the second an minutes administer station of the drugs. and the physicians needed to be able to provide ongoing care. and the fda also said, the percentage of women who considered any adverse event to severe ranged from 2 to 35 percent and the fda included a black box

warning which you are familiar with which remains on the drug. those restrictions were largely in place until a couple of years ago when the biden administration after the united states supreme court took up the dobbs decisionings, decisiot that point the biden administration decided to eliminate 20-years of dispensing requirements for this drug. they didn't cite anything that was adequate. the fda said the studies they looked at did not take into account of the protocols that they were implementing they just eliminated two decades of dispensing requirements. my question to you is doesn't it make sense that the fda return to the prepolitical for the intervention of the biden administration the prepolitical protocol for dispensing these

drugs. >> i do think it makes sense to review the totality of data and ongoing data. i know personally ob doctors who prefer to insist even though they have the option to prescribe otherwise they prove to insist that the mifepristone be taken in their office. and i think there concern is if this drug is in the wrong hands it could be used for coercion. >> now it's not nearly that there is no requirement that it be ingested in front of a physician there is no dispensing requirements, two decades of dispensing require manies the biden administration eliminated. the obama administration

eliminated the the requirement for the data for adverse events. >> i think they limited the -- i'm happy to look at that and i don't believe in prejudging data before someone has taken a look at data including future data. let me just say, here is the deal. the fda rules were consistent and table for 20 plus years until suddenly the dobbs decision were on the horizon and since then we had massive changes of this drug. and 60 percent of abortions are carried out with these drugs. without any physician supervision. without any physician there if there is a serious adverse event.

i will also point out if the biden rules are allowed to stand, it doesn't matter what the voters in the states. this is it a serious and difficult morale issue the case of life and abortion. the biden administration says you can mail in abortion drugs to each state. it doesn't matter what the voters in each state say. if that is allowed to stand we may as well go back to having the supreme court make all of the decisions. the doctors are not involved, they are not in person dispensing and this is extremely concerning to me. and it ought to be voters in states and the relevant localities that are making this decision. i know you are familiar with this doctor.

and i appreciate your commitment to the data and i hope we can count on you to protect women's health and the unborn. let the record reflect even though i have the gavel i'm going to turn it over to you. >> senator holly and i share a unique perspective. there are two sets of senators that went to the same high school. we went to rockhurst high school in kansas city. >> i loved the opportunity to visit with you and i know the answer to this question. i want to stress it again. you didn't have anything to do with the layoff of the fda employers the past couple of weeks. >> that is correct. >> do you know who made the decision or what groups of people were laid off. >> i do not, senator. >> you indicated when

you come into the office you are going to do an assessment. and i suppose based on your experience if you look at this going forward personal policy including layoff should be done strategically instead of willy nilly across the board randomly, correct i'm >> i'm open to ideas to running the government efficient. >> do you think running them willy nilly across the board is a good idea or not a good idea. >> i'm a surgeon so i'm going to give you a surgical answer. >> it's a little puzzling the administration has high confidence for you. you have this hearing right now and they expect you to be confirmed, probably will be with the practice of the notion to law off a thousand people before you got there is unusual what we're seeing in the agency is that it's willie nilly and probationers are laid off because they can't

fight back. probationers are not veterans. i'm glad with you are a you are asurgeon and will act like a surgeon when confirmed. >> we agree that despite with the needs of reforms for the fda it's the gold standard and i asked if there was another nation that does it better than us. and you said no there wasn't, even though you have reformation you would -- reforms you would like to make. >> we talked about tracking a events after a drug or medical device is approved. you said the fda can do a better job it's not all about approval but it's about post approval tracking. there are many different user fee programs that outline. and for most of the user fee programs except

medical device user fee the fda can use the user fee dollars. >> do you believe that the fda should be able to use user fees for post selected. >> i very much enjoyed our conversation and as you know i'm committed to a fda that delivers more cures for americans and meaningful treatments and healthy food for children. >> to you think post approval surveillance is important. >> i'm a big believer in the idea that we should not turn a blind eye after the fda approves something if we do we

get burned with thing like oxyco-done it's o odd we don't have that on post surgical devices and we do in our areas. on oxycon, we're seeing some improvements. 24 percent decline drug overdose in the period ending in 2024 and yesterday the nih released findings of an nih study for a new path way for pain issues. so it's an improvement, but we have so much further to go. and one in four virginiaians deal with chronic pain. and can the fda not just be in receive moved to get the applications for approvals and can the fda be proactive and say

how come we don't have non-opioids based pain strategy. to look at gaps and to try to incentivize or encourage filling those gaps would be smart. could you share your ideas of how we can have the development of innovative strategies to address. >> i brief the fda should not only be in receiver mode but partner with the process. looking at postapproval monitoring of devices. sen. kaine: i look forward to more discussion.

sen. tuberville: world war ii, we had to find ways to feed our troops. we knew nothing about preservatives and canning foods. ever since then our food has gone downhill because we have put everything in the world in our food. getting kids addicted to it, which we have peered we probably lost a couple of generations because of obesity and diabetes. i have faith in this generation, i have two kids in the generation coming up. they're looking at their health as their future and are fired up about it. nutrition being a good part of it. you are familiar with grass, generally recognized safe foods. >> what are your thoughts about that as an fda director, we're

not using this chemical in this food, what is your thoughts. >> first of all, isn't senator, coach, you have had a perspective on this and been an advocate for healthy foods because you have a unique position working with children so look. half of our nation's children are sick. we final have an agreement to address the root cause of these diseases. and good has a part of it. a big part of it. when we eat foods with a lot of molecules that don't appear in nature. these are chemicals that the industry insises are safe. there is a body of research that has concern with some of these ingredients.

and you have my commitment to do so if confirmed as fda commissioner. with an alter micro- -- and they don't feel well. what are we doing? we're drugging our nation's children at scale. we have to reassess what we're doing. >> i grew up in the south and i love fried foods and we fry everything including snicker bars and twinkies. let me ask you this. we hear a lot about seed oils the good and the bad, your thoughts. >> seed oils are an example of where we can benefit from scientific research. i don't think it's anyone ingredient that is making our nation's

children sick with a 30 percent rate of insulin resistance and diabetes in children today. that is a mass massive signal. when we're using tax dollars to make purchases of foods that we know make our nation's children sick, we have to rebeen how how -- re-examination how we're spending hour tax dollars. one thing i want to work on is a a pilot to transition to healthier foods. many school districts want to but they don't know how. i have been discussing this with the administration and i hope this is something that we can do. >> a few months ago we had the former fda director and i asked him about red dye no. 3 and it was a pretty

interesting conversation. red dye no. 3 and we have done studies on it we won't allow it in cosmetics because it causes cancer and we're allowed to put it in your food. put it on your face or in your stomach there is no difference. he said we're 20-years behind europe on looking into red dye 3 and other dyes. what is your thought? >> i agree it doesn't make sense that red dye was in banned in cosmetics and not in food. so there is a plan to

have it banned by 2028? >> why would you want to put our people in harm's way? >> thank you. >> thank you mr. chair and thank you dr. for your service. i looked over your three books the three books that i was able to chase down and each one seemed provocative and full of answers. i'm a slow reader i'm dyslexic so i wish you had cliff notes so we could get 10 or 15 pages to summarize that. >> i appreciate your courage in taking on these traditional approaches and being can candid. let me take a few questions. in a few weeks a lot of

fda staff have been laid off and most of these inspectors who were looking at food supplies to make sure they are safe. and for the fda inspectors the job vacancies have been going up not down. we have more unfilled spots and then all of a sudden we have laid off off10% of the people there that is going to have a problem with moral and how are you going to ensure the fda's gold science if we can't get enough inspectors. >> i wasn't involved in any personnel decisions. >> once you get in the job and your budget is diminished and you have fewer inspectors and you already didn't have enough by the existing

measures, i'm not sure there is an answer for it. maybe it's an unfair question. >> senator if confirmed you have my commitment that i will do an anassessment within the agency to ensure that the scientists and the food inspectors have all of the resources they need to do their job. >> great, that is the exact place to start. we have a bill skinny labels big savings act that helps more generic drugs and more competition coming into the market and lower drug costs. again, with so many of the fda workers having been fired and laid off, will there be sufficient people at the agency to review generic drug applications? because that often gets pushed to the bottom of the heap and that has dramatic savings for people people that don't have insurance. are you worried about slow down again due to

resources and personnel >> senator i want to make sure that the reviewers and process is done without cutting any corners and done ex-pee d expi right.the fda has almost 19,000 employees. that represents a 100 percent increase since 2007. now i understand there were some lay-offs recently. i understand that some or many were hired back. i wanted to let you know to put things in context, we have seen a doubling of the agency in terms of number of employees since 2007. >> i accept that. and i was aware of that. but it's a fair point. a lot of talk about

measles. secretary kennedy recommended the use of cod liver oil one of several things that people could do and left it to parental discretion as to whether they would get their kids vaccinated. i agree with that. i think the parents in the end have a right and responsibility to make that decision for their kids. but it seemed to me that there could be a stronger -- those that looked at in-depth and in detail at the facts that this is really a very safe vaccination for 99.99 percent of kids and it saves lives and prevents huge levels of very sick kids. do you think there should be more or would be be more of a willing supporter of vaccinations at the same time recognizing that the parents get the final say. >> senator, vaccines save lives. and i do believe that any child who dice of a

vaccine preventible illness is a tragedy in the modern era. the rare times in which a child dies of measles is it's often in a setting of a severe malnutrition. and that is the rational as to why supplementtion in terms of nutrients may provide a benefit for children who are very sick and hospitalized with measles. >> i don't deny that. >> thank you senator. >> thank you, mr. chairman. great to have you before the committee. i enjoyed dr. makary the conversation that we had in my office and i want to give you a chance to share some thoughts building on what others have asked you.

i am deeply concerned about how much inflationary cost the healthcare system has created for the american public in the last decade. in the 21st century the most inflationary cost affecting consumers and businessessed american taxpayers is healthcare costs. we spend more and get worse outcomes. you look at the fact from the early stages we have children who are unhealthier, worse diets and more obe wan obesity and that leads to diabetes and higher costs in the healthcare system that continues to manifest through life on all of those fronts and then the government and the taxpayers pay for it through medicare and medicaid. and it's driving us into

bankruptcy at some levels and costing people and families the ability to be able to afford to live. and so there are lots of ingredients to that. how do we take costs out of the healthcare system and making people healthier in making this whole system sustainable for the long run. >> well thank you, senator, and it's good to see the cavaliers doing great this year. i hope it's their year to win it all. and i enjoyed our time in your office. >> we had only one championship in cleveland and that was when lebron was there. >> first of all you are 100 percent connect and that is something that i'm passionate about and healthcare costs are spiraling out of control and it's burdening every day businesses and families. it's getting more

when we are spending money that we don't have as a country, it drives inflation and inflation is a backhanded dirty tax on the poor. it doesn't affect the wealthy, it affects the poor. that's why we've got to address health care spending. be part of many different ideas out there, but the main root issue is the health of a population and it is getting worse. 75% of adults have some comorbid condition or diabetes or prediabetes were are overweight or obese. three in 10 teenagers of insulin resistance. that's not good for our future as a country. thanks to president trump and secretary kennedy, for the first time we are talking about root causes, both on a research basis and in terms of what we could do at every agency. within the fda there are things we could do to help empower people by facilitating this

independent scientific review of devices and other ways to prevent chronic diseases with continuous glucose monitoring, continuous blood pressure monitoring and healthy foods for children. if confirmed, my goals are very clear at the fda. more cures and meaningful treatments for americans, including diagnostics. healthy food for children and rebuilding the public trust. >> i look forward to working with you on all those issues, i'm sure many members of the committee do. one way that we can drive more efficiency in speed to market for things that can improve lives and hopefully lower costs is through technology. i know i was involved with the cleveland clinic when they got the first quantum computer focused on health care research and use things like quantum in ai to drive discoveries, speed to market with these. could you talk about how the fda, under your leadership, with think about those things. >> thank you, senator.

there's a number of opportunities with ai right now that we have that we have never had before. we have an incredible opportunity to use ai to help reviewers in the review process, not to replace the human reviews, but to aid them and assist them in the same way that ekgs are read by ai devices that tell us a normal sinus rhythm at the bottom of the ekg. we still look at the rhythm, but it may help the efficiency among the reviewers. we could use ai in drug design and drug development. that's not something the fda does but the fda can help provide data to help train machine learning models to help design ai systems that can predict toxicities, adverse events, and even cures for some conditions. finally, ai can be used to aid with data monitoring and a postapproval setting. we don't learn five years after its approve that 38,000 americans died from it.

>> thank you senator. click thank you, mr. chairman. i'm from boston, home of the world champion boston celtics. but we will have a little bit. you stated that you wanted to ensure that the fda holds the gold standard of trusted science and transparency. in order for that to happen the fda commissioner holds the gold standard for trusted science and transparency. in your financial disclosures you disclosed you made over half $1 million from global appropriateness measures, llc, the client list for their company includes companies that are interested in making money off the health care system insurance companies, hospital chains, private equity companies, so can you tell the committee how much you made from those private equity and venture

capital backed companies. >> iq for the question, i enjoyed our conversation prior to this hearing. i'm very proud of my work at global appropriateness measures. the purpose of the endeavor was to lower health care costs for americans by reducing unnecessary surgery and medications. ask for the record, can you tell us how much you made from the private equity and venture capital backed companies? >> i have been a shareholder in global appropriateness measures, i am fully divesting, i don't have the exact numbers at my fingertips but they were all disclose to the office of government at the and they are all part of the disclosure systems. >> was in the millions of dollars or less? >> over the course of what time? >> over the time you have a relationship? >> there was revenue of that company in the millions of dollars, yes. and i am one of the shareholders of that company, and i'm very

proud. the best way to lower drug prices in the united states are to stop taking drugs we don't need. i do believe in the appropriateness of care in that endeavor was designed to create a software so we can monitor. >> i appreciate that. we are just looking at the transparency. i'm just trying to help you be transparent. how much were you paid by insurance companies, included devoted health insurance companies that primarily sells medicare advantage? quickset figures in the office of government ethics report, i don't have that exact number at my fingertips. >> was that in the millions of dollars as well? >> that was far less. again, i am a shareholder, so i'm one of the shareholders of that company. >> i think the american people deserve full transparency about you might be influenced by the health-care industry and insurance company, private

equity, venture capitalist funds and that's what we are trying to get out. >> all of those reports will be public. >> they are not public at this point so i'm not in a position to ask you about them, that's why i'm asking you. >> office of government of ethics releases it. >> it's not helpful for the confirmation. it's essential in terms of the public understanding all of the potential conflicts of interest that might show up. the fda is responsible for approving medical devices on drugs with a impact how much insurance pay, with a cover for the same insurance companies that do overcharge americans. under cover of the care it will impact private equity, and you are coming into this role with relationships pre-existing that have a profit interest in the decisions that you will be responsible for making. that's why raise these issues. will you commit today to not

participate in any decisions that would have an impact on known clients of global appropriateness measures during your tenure as fda commissioner? quick senator, i appreciate your enthusiasm on this topic. i am one of the biggest advocates that was involved in the health insurance industry transparency of the secret negotiated rates. so i am with you. the recusal's i will be taking our 100% in line with the office of government ethics recommendation, which are not to resign from everything, but i chose to resign from everything to ensure no appearance of a conflict of interest. >> the same thing will you commit today to not participate in any decisions that would have an impact on private equity and venture capital of those clients as well? >> senator i commit to following

the office of government ethics agreement. >> again, it's important for us to understand this going forward because of the increase of moral sectors and they will be influencing the sectors of fda. >> on that note, they've been very transparent, right? talk about the process, how transparent you have to be to get to this point today? >> there was a massive disclosure of basically every single share of everything that i own and that process took a number of weeks, and i would describe it as a colonoscopy

with a small bowel follow-through. everything is out there and basically i will have essentially no privacy when the office of government at the chooses to release that. but that's ok. i'm proud of everything that i've done and i'm more than happy to acknowledge that i have agreed to divest or resign from everything, so i was given the option not to resign from everything and i chose to resign from everything. i want to ensure independence, this is not a job i'm taking to audition for my next job. this is a job i'm doing to serve the american public. i believe in more curious and meaningful treatments, healthy food for children and rebuilding the public trust, so, senator, i can commit to you that i am absolutely dedicated to that mission and i'm not there to audition for a future job. >> i appreciate that because this is so important. you been nominated for this position because you are incredibly accomplished, your background perfectly fits the role you are about to take any

bring experiences and success to the table to be the new head of the fda and change it because you have talked about this, you mentioned in your testimony that health care has become too fragmented, too cold and too corporate. and you are going to go there to shake that up and change that. the make america healthy again movement that was a big part of giving this president a giant mandate with secretary kennedy and others coming to the table, the role you are going to play is really important to that, to disrupt it, and i think we all agree that i think the american people agree that the medical establishment is often condescending towards the american people is something we have to disrupt and change. can you talk about how you will do that at the fda? >> i do agree 100 percent that for the first time ever, president trump and secretary kennedy had moms that were republican, democrat,

independent, come out and vote because they care deeply about the health of our nation's children. they want to see healthier food for children. they want to see in industry -- they want to see an fda that is independent of corporate influence, but at the same time working with partnerships around the country to facilitate, not just being receive only mode. one of my goals is to ensure that the fda maintains its scientific integrity, and that we can do what we can to contribute to the make america healthy again spirit. >> clinical and nonclinical testing are both very important parts of fda's drug approval process. how do we modernize that process, modernize testing? >> first of all, there are steps in the regulatory process where we can take a look and ask, do we need to use the same processes that we've been using?

infant formula, for example, has had the same recipe for the last 40 years. so, with the exception of selenium, which was added in 2015, for 40 years we are requiring formula companies to use a standard recipe that was developed back when the food pyramid was misleading americans and basically government misinformation, can we take another look at that? can we create other ways in which new products can be brought to market safely, can we look at real-world data from european products? the more competition, the more resiliency in the supply chain in the lower the risk of shortage in the future. so does the infant formula need to go through the same process as a new drug, or can we look at real-world data and work with the companies to figure out a smarter way that uses both trusted science and common sense, which is a theme i would like if confirmed. >> i would work with you on

that. the fda starting to allow students to choose whether they allow fda instructions on paper or digitally. it seems like common sense. but a medical device instructions are still required to be on paper. would you support changing that requirement? >> my understanding is that is a requirement set by congress and i would be more than happy to work with you and members of congress. i have heard arguments on both sides, one thing that people have raised is that, on one hand, it may be a waste of paper. on the other hand seniors may not go to a website to look at the information so i think there are arguments on both sides. i welcome the opportunity to work with you on reforming. >> senator alsobrooks? >> if you missed her chair. good morning. good to see you here. i am going to just feed off of something my colleague just mention, which i think is significant.

he said the a medical establishment is condescending to the american people and i would like to offer that, unfortunately, because this administration has been so reckless in the way that has handled civil service, it would be condescending -- many of them are my constituents who work in institutions like johns hopkins and who are serving the people. and, many of the actions of this administration have been quite chaotic and confusing, so i want to draw you to a few things. the committee staff raise last week a memo that was put out by opm and this memo directed agencies to dramatically reduce staff, then they reversed themselves, i'm not sure whether you've seen the latest guidance from opm this week, which dot -- backtracked that directive to fire employees and said sit said they clarified that the decisions to fire should be left individual agencies. i would like to just ask you, given this updated guidance, whether we have your assurance

here today at this hearing, that you will not arbitrarily fire employees at fda given the new guidance. >> first of all, senator. good to see you and i enjoyed our conversation and i'm very proud to work at johns hopkins in the state of maryland. i'm a big believer in the professional career of staff at the fda, which is also located, by and large, most of the employees are in maryland. you have my promise that if confirmed, i will do my own independent assessment on personnel. i welcome input on efficiencies at the agencies. at the same time i want to make sure that the scientists and food inspectors and staff at the core mission of the agency have all the resources they need to do their job well. >> as you mentioned, there are so many valuable members, fda does a tremendous service for our country and they handle drug safety, as you know, we think

about reviewing medical devices is any mention infant formula, where many women are designated as the people who would make sure that those items are safe are the ones who have been terminated. so i would like to know whether you would commit to rescinding determination of scientists who were working to address the bird flu? >> i was not involved in any of those personal decisions, if confirmed, i would certainly do an assessment. >> he will go back and look at those terminations? >> happy to, senator. >> as well as the fda food division and people who keep our food safe, you would commit to them going back and looking up those terminations to make an independent assessment? >> of course, happy to. >> in the same vein, i wonder whether you realize that many of fda's salaries, you may already know this, are paid in large not by taxpayers, but by user fees,

are you familiar with that? >> sim, senator. >> the concept of the recent or terminate these employees is to save taxpayer dollars is one based on the premise that is largely not true since we use the user fees for many of the salaries. that being the case, whether you would commit to rehiring their 100 employees that were fired from fda's tobacco center, which is 100% funded by user fees. would you commit to going back and looking to rehire the 100 who were terminated? >> senator, if an employee has not logged on to their vpn in two years, them i don't want to rehire that individual. but if there are people that deserve a look, i am happy to look at that. >> we are talking about a big lie out there that says these civil servants are lazy, shiftless, they don't show up, that is by and large not true. i'm asking if you would look at the ones who have been summarily terminated without cause in your answer to that has been yes you

would go back and make your own independent assessment. >> i would do an assessment if confirmed, thank you. >> finally, on tuesday does made the release of over 400 government buildings that they want to dispose of and many of these are in white oak campus, which is in maryland, one is in a building called building number one and i wonder whether you are familiar with building number one. >> are not familiar with the numbering of the buildings. >> that's where your office would be and that's one of the buildings that they have put on the list to close, shutter and close up. again, just pointing out that many of this decisions arbitrary and they harm the work that we do and harm the american people and just wanted to ask you if you would be committed to making decisions that make sense and do not eliminate the fda. >> i believe in common and trusted science and if confirmed, you have my commitment to do an assessment of personnel to look at efficiencies. i welcome the input of any

organization, of any individual member of congress from the administration and the d oge team as well and figure out how the government can be more efficient as well. >> i would like to submit an article referenced by health committee witness and a portion of melissa regarding a woman who took this drug twice, including once obtaining it online and taking outside the fda's window. she still deliver her baby. fda has conducted safety studies on the product, i'm not aware that they studied any safety outcomes related to a child who might still be born. as a physician, sending women abortion pills without a complete evaluation of the gestation of her pregnancy were checking for an ectopic pregnancy is clearly a safety issue. that's why would urge him to return to the policies during

the first trump administration requiring an in person visit. with that, this concludes our hearing, and i will say that i know your family is incredibly proud of you, and i just thank them for being here as well. believe me, you are in for a ride. thank you for volunteering along with the doctor. for any senators who wish to ask additional questions, questions for the record will be due tomorrow at 5:00 p.m. this concludes the hearing. [applause] [captions copyright national cable satellite corp. 2025] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. visit ncicap.org] click c-span's washington journal, our live forum involving you to discuss the latest issues in government. -- government, politics and public policy, from washington and across the country, coming up friday morning we talk with

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